Chronic, Medically Refractory Headache Clinical Trial
Official title:
Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
| NCT number | NCT01050959 |
| Other study ID # | A4005 |
| Secondary ID | G030225/S022 |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2010 |
| Est. completion date | April 2011 |
| Verified date | November 2013 |
| Source | Boston Scientific Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | April 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system. - Subject elects to enroll in this compassionate use study and provides written informed consent. - Subject understands the type and duration of clinical, technical or product support provided in the study. - Subject is willing to comply with protocol-required activities. Exclusion Criteria: - Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan |
| United States | Mayo Clinic Arizona | Phoenix | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Provision of one year of clinical and technical support | This is a compassionate use study. There are no primary outcome measures. |